Advisers to the European Medicines Agency on Friday recommended limiting the use of a group of widely prescribed inflammatory disease drugs due to safety concerns, following a similar, but more restrictive ruling last year by regulators in the U.S.
The EMA’s Committee for Medicinal Products for Human Use endorsed a recent recommendation from the agency’s safety panel to restrict use of so-called JAK inhibitors in patients who are at least 65 years old, at increased risk of major heart disease or cancer, or are active or long-time smokers. Those drugs should only be used if “no suitable treatment alternatives are available,” the committee said.
The committee also cautioned use of the treatments in patients with a higher risk of blood clots in the lungs and deep vein thrombosis. Those patients, as well as the ones at risk of cancer or heart disease, should get a lower dose of the drug, the committee said.
The European Commission is expected to sign off on the recommendations, which would apply to Pfizer’s Xeljanz and Cibinqo, Eli Lilly’s Olumiant, AbbVie’s Rinvoq and Galapagos’ Jyseleca. All of them are marketed in Europe and would have their product information updated with the new warnings and recommendations.
JAK inhibitors, which block enzymes associated with inflammation, are meant to be a convenient alternative to injectable biologics like Humira for treating a range of inflammatory diseases. But they have drawn increasing scrutiny from drug regulators in recent years after clinical studies and post-marketing tests unearthed risks of heart attacks, stroke, cancer, blood clots and serious infections.
Those risks led the Food and Drug Administration last year to significantly curtail use of JAK inhibitors in all patients, only allowing their use when drugs like Humira don’t work. Europe’s policy is less restrictive, but nonetheless will limit their use in one of the world’s largest commercial markets.
The EMA was mainly concerned with use of the drugs in older patients, but the inclusion of smoking as a risk factor, which could apply to 18% to 29% of the EU, “may still cap, along with increased safety vigilance overall, what the long-term opportunity could have once been,” RBC Capital Markets analyst Brian Abrahams wrote in a note last month.
The company most directly affected by the EMA’s recommendation is Belgian biotech Galapagos, whose only marketed product is the JAK inhibitor Jyseleca. The drug accounted for all of the company’s 60.5 million euros, or about $62.5 million in sales revenue in the first nine months of the year. It’s cleared in Europe and Japan for rheumatoid arthritis and ulcerative colitis. Still, RBC analyst Abrahams isn’t expecting a significant impact on sales given the EMA’s “relatively benign safety language” compared to the FDA.
The EMA’s recommendation is a “positive evolution in supporting the best use of the JAK inhibitor class,” said Galapagos chief medical officer Walid Abi-Saab in a statement Friday.